MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	B2040-100
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was a procedure to treat a moderately calcified and moderately tortuous lesion in the superior femoral artery.An armada35 4x100mm balloon catheter was prepared per the instructions for use (ifu) and was inserted without issues.Once the device reached the target lesion, the balloon was attempted to be inflated.However, when the balloon was attempted to be inflated at normal pressure, the balloon did not fully expand.At this moment, the physician noticed that a leak occurred in the hub; therefore, the balloon catheter was removed and replaced with a same size balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and functional inspections were performed on the returned device and the reported leak and inflation issue were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the noted tears.It may be possible that the guide wire used in the procedure was damaged, causing the tears on the inner member during loading of the guide wire; however, this could not be confirmed.Although a conclusive cause for the noted tears was unable to be concluded, the reported leak and inflation issue appears to be related to operation circumstanced of the procedure as it is likely that the tears on the im resulted in the leak and inflation issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10561022
• Report Number: 2024168-2020-07853
• Device Sequence Number: 1218767
• Product Code: LIT
• UDI-Device Identifier: 08717648155116
• UDI-Public: 08717648155116
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: B2040-100
• Device Catalogue Number: B2040-100
• Device Lot Number: 00106G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 08/29/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE; GUIDE WIRE
• Patient Age: 61 YR
• Patient Weight: 73